Smoking CessationSNTQNCT02085616
Effectiveness of the Swedish National Tobacco Quitline
A study testing Proactive service and Reactive service in people with Smoking Cessation and Tobacco Cessation, run by Uppsala University at 3 sites in Sweden.
Trial summary
The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Cessation, Tobacco Cessation
- What is being tested?
- Proactive service and Reactive service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tobacco users calling the SNTQ to discuss his/her own tobacco behaviour.
- The client gives verbal consent to sign up for cessation support.
- The client return a registration form including a baseline questionnaire
Who cannot join
- Snuff cessation
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Karolinska Institutet
Stockholm, 17177
Stockholm County Council
Stockholm, 17177
Centre for Clinical Research
Västerås, 72189
About this study
Official title: Smoking Cessation by Telephone. Effectiveness and Cost-effectiveness of Proactive and Reactive Services at the Swedish National Tobacco Quitline (SNTQ).
The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service.
The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to offer the client a choice of callback (proactive service) or no callback (reactive service). In the present study clients were not offered a choice, but were randomized to proactive service on even dates and to reactive service on odd dates. Data are collected through postal questionnaires, one baseline and one follow-up after 12 months.
- Conditions
- Smoking Cessation, Tobacco Cessation
- Being tested
- Proactive service, Reactive service
- Keywords
- Smoking cessation, Tobacco cessation, Quitline, Telephone counselling, Intensity
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive serviceBehavioural
In the proactive service the callers to the quitline are offered a number of callbacks.
Reactive serviceBehavioural
In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like.
| Study group | Role | What they receive |
|---|---|---|
| Proactive service | Experimental | Intervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the proactive service the callers to the quitline are offered a number of callbacks. Receives: Behavioral: Proactive service |
| Reactive service | Active comparator | Intervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like. Receives: Behavioral: Reactive service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence
Not a puff in the last week
Measured: 12 months
Secondary outcomes (1)
6-month continuous abstinence
Not a puff in the last 6 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Interim analysis, revealed no additional effect of proactive over reactive service.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm, Västmanland County Council, Sweden, Swedish Heart Lung Foundation, Swedish Cancer Society, The Swedish Research Council, Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Hans Gilljam, Prof, Principal investigator, Karolinska InstitutetÁsgeir R Helgason, Assoc prof, Principal investigator, Karolisnka InstitutetEva Nohlert, PhD, Principal investigator, Centre for Clinical Research Västerås, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085616
- Sponsor's protocol ID
- SRL00-367
- Acronym
- SNTQ
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
Publications
Nohlert E, Ohrvik J, Helgason AR. Self-perceived ability to cope with stress and depressive mood without smoking predicts successful smoking cessation 12 months later in a quitline setting: a secondary analysis of a randomized trial. BMC Public Health. 2018 Aug 28;18(1):1066. doi: 10.1186/s12889-018-5973-9.
PubMed 30153814Nohlert E, Ohrvik J, Helgason AR. Effectiveness of proactive and reactive services at the Swedish National Tobacco Quitline in a randomized trial. Tob Induc Dis. 2014 Jun 3;12(1):9. doi: 10.1186/1617-9625-12-9. eCollection 2014.
PubMed 24936168
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation by Telephone. Effectiveness and Cost-effectiveness of Proactive and Reactive Services at the Swedish National Tobacco Quitline (SNTQ).
- ClinicalTrials.gov ID
- NCT02085616
- Acronym / sponsor ID
- SNTQ / SRL00-367
- Conditions
- Smoking Cessation, Tobacco Cessation
- Keywords
- Smoking cessation, Tobacco cessation, Quitline, Telephone counselling, Intensity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis, revealed no additional effect of proactive over reactive service.
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm, Västmanland County Council, Sweden, Swedish Heart Lung Foundation, Swedish Cancer Society, The Swedish Research Council, Swedish Council for Working Life and Social Research
- Study start
- Feb 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service.
The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to offer the client a choice of callback (proactive service) or no callback (reactive service). In the present study clients were not offered a choice, but were randomized to proactive service on even dates and to reactive service on odd dates. Data are collected through postal questionnaires, one baseline and one follow-up after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive service | Experimental | Behavioral: Proactive serviceIntervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the proactive service the callers to the quitline are offered a number of callbacks. |
| Reactive service | Active comparator | Behavioral: Reactive serviceIntervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Tobacco users calling the SNTQ to discuss his/her own tobacco behaviour.
- The client gives verbal consent to sign up for cessation support.
- The client return a registration form including a baseline questionnaire
Key exclusion criteria (1 listed)
- Snuff cessation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive serviceIn the proactive service the callers to the quitline are offered a number of callbacks. | Behavioural | Proactive service |
| Reactive serviceIn the reactive service the callers to the quitline are informed that they can themselves call back whenever they like. | Behavioural | Reactive service |
Primary outcome
Point prevalence abstinence
Time frame: 12 months
Not a puff in the last week
1 secondary outcome
6-month continuous abstinence
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Interim analysis, revealed no additional effect of proactive over reactive service.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Derived from this study: PubMed 30153814Nohlert E, Ohrvik J, Helgason AR. Self-perceived ability to cope with stress and depressive mood without smoking predicts successful smoking cessation 12 months later in a quitline setting: a secondary analysis of a randomized trial. BMC Public Health. 2018 Aug 28;18(1):1066. doi: 10.1186/s12889-018-5973-9.
- Derived from this study: PubMed 24936168Nohlert E, Ohrvik J, Helgason AR. Effectiveness of proactive and reactive services at the Swedish National Tobacco Quitline in a randomized trial. Tob Induc Dis. 2014 Jun 3;12(1):9. doi: 10.1186/1617-9625-12-9. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gilljam, Prof principal investigator
Karolinska Institutet
Ásgeir R Helgason, Assoc prof principal investigator
Karolisnka Institutet
Eva Nohlert, PhD principal investigator
Centre for Clinical Research Västerås, Uppsala University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive service and Reactive service in people with Smoking Cessation and Tobacco Cessation, run by Uppsala University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis, revealed no additional effect of proactive over reactive service.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.